At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 30 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
OSMITTER 316-13-206A Substudy: A Substudy to Measure the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1) System and Determine the Latency Period
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Mar 19, 2014·Updated Oct 26, 2021
In Brief
A Phase 4 clinical trial evaluating Placebo and Combination product of Aripiprazole + IEM + Sensor + MIND1 Application for Device Latency. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDevice Latency
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartMar 2014
Primary CompletionApr 2014
TodayJul 2026
First PostedMar 19, 2014
Enrollment StartMar 21, 2014
Primary CompletionApr 18, 2014
TodayJul 2, 2026
Enrollment to primary: 27 daysPosted 12.3 years ago
Interventions
Placebodrug
Oral placebo-embedded IEM tablet.
Combination product of Aripiprazole + IEM + Sensor + MIND1 Applicationcombination
Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on smartphone